GOED prepares omega-3 authorized health claim submission

By Lorraine Heller

- Last updated on GMT

Related tags: Health claim, Omega-3 fatty acid, Nutrition, Epa

An omega-3 trade association is preparing to apply to the FDA for an upgrade of the heart health claim linked to omega-3s from a qualified health claim to an authorized health claim.

According to the Global Organization for EPA and DHA (GOED), a “full”​ health claim for omega-3 would communicate a clearer message to consumers, and ensure adequate levels of the essential fatty acids are used in fortified food and beverage products carrying the claim.

The organization’s executive director Adam Ismail told NutraIngredients-USA.com last week that it is preparing a dossier with the necessary supporting evidence, which it expects to submit to the US regulator “in early 2009”.

FDA would then – in theory – have 180 days to respond, although it may well extend that period.

“A full health claim would help consumer education because it’s very clear and easy-to-understand,”​ said Ismail.

“It will also hopefully attach a level that’s required for consumers to obtain the heart benefits – because food companies right now can put in any level of EPA and DHA and make the qualified health claim.”

Qualified claims

Currently, the only claim associated with omega-3 is a qualified health claim for reduced risk of coronary heart disease (CHD) on conventional foods that contain eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3 fatty acids.

Qualified health claims are those based on emerging evidence for the relationship between a food or supplement and a reduced risk of disease.

Because the evidence is not well enough established to meet the significant scientific agreement standard, this type of claim must include qualifying language to indicate that the evidence supporting the claim is limited.

Passed in 2004, the omega-3 claim for foods follows a similar claim announced in 2000 for use on dietary supplements.

The claim reads: "Supportive but not conclusive research shows that consumption of EPA and DHA omega-3 fatty acids may reduce the risk of coronary heart disease. One serving of [name of food] provides [x] grams of EPA and DHA omega-3 fatty acids. [See nutrition information for total fat, saturated fat and cholesterol content.]”

Authorized claims

NLEA Authorized Health Claims are provided for by the Nutrition Labeling and Education Act (NLEA) of 1990. These claims are based on a significant scientific agreement standard (click here​ for more information), which determines that the nutrient/disease relationship is well established.

Authorized health claims can also be based on an authoritative statement from a scientific body of the US government or National Academy of Sciences.

An example of such a claim for omega-3 would be: “EPA and DHA may reduce the risk of heart disease”.

Manufacturers can use this latter type of claim on foods and beverages - but not dietary supplements - following successful notification to FDA. (Click here​ for FDA's guide on how to make authoritative statement-based claims.)

Omega-3 levels

Although an authorized health claim may not mention the level of EPA and DHA necessary for heart health, the use of the claim would be possible only on products that contain high enough levels to exert the benefit.

Such levels have not yet been formally set, but scientific consensus indicates that this level needs to be around 500mg EPA and DHA per day.

Currently, products that contain less that that – or even products that contain other forms of omega-3, such as the shorter chain ALA, that do not carry the same scientific backing for their health benefits – can carry the qualified omega-3 health claim.

This has created an environment of marketplace confusion and consumer misinformation.

An authorized health claim could be one step in the direction of establishing a much-called-for omega-3 RDI (recommended daily intake).

European claims

GOED told NutraIngredients-USA.com that its submission to FDA for an authorized omega-3 health claim would follow its application for a health claim in Europe under the European Union’s new health claims system.

The organization is currently preparing a dossier to submit to the European Commission under Article 14, which it expects to submit early next year.

As soon as that is completed, the supporting data will be repackaged and submitted to FDA.

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